Regulatory-Affairs-Spezialist (m/f/d)

Start your career at VYGON and contribute to a meaningful mission: Value Life. We develop, manufacture and distribute high-tech products by guaranteeing the traceability of our products from development to distribution through quality controls. Today, our group consists of 26 subsidiaries and eleven production sites, of which eight in Europe. To work with VYGON means to be part of an international group, but also an independent company. Thanks to the work of our 2.619 employees, VYGON produces approximately 210 million medical devices every year. At VYGON, integrity, commitment, determination, efforts to improve and respect for people are at the centre of our action. We are committed to a multi-faceted and integrative working environment and our recruitment process is designed to give all the applicants equal opportunities. We are looking for you Senior Consultant (m/w/d)

Preparation, preparation and maintenance of technical documentation for national and international product authorisations with a focus on Europe and USA Compilation of technical documentation for international product registrations by the parent company Planning and implementation of PMCF activities Creation and updating of plans and reports according to MDR (e.g. SSCP reports, PMCF reports, PSUR) Close technical cooperation with product development Support and care of the EUDAMED database Communication with Authorisation Bodies and Authorities Preparation of data for the preparation of biological and clinical evaluations Monitoring legal and normative requirements Creation and maintenance of documents for the quality management system according to ISO 13485 and MDR Communication with the VYGON subsidiaries Monitoring and monitoring of audits and inspections

Complete technical or natural science studies, preferably biomedical technology, microbiology, process engineering, etc. Multiannual professional experience in the admission of medical devices and the creation of technical documentation Knowledge of the legal requirements for medical devices (e.g. Regulation [EU] 2017/745 MDR, EC and FDA Directives) Analytical, process- and solution-oriented thinking and action combined with very good technical understanding Structured, conscientious and team-oriented work and a convincing communication capability Place of use: Location: Aachen, Germany Qualification: Minimum requirements Training: Bachelor Minimum requirements of professional experience: 2–5 years Languages: German (safe for negotiation) English (safe for negotiation)

Continuous, crisis-proof and future-proof workplace in a high-growth company Attractive remuneration according to the collective agreement of the chemical industry Occupational pension, holiday allowance, 13. Monthly salary and numerous social benefits Modern time recording with sliding time accounts and 30 holiday days Extensive onboarding including Welcome Day Free drinks and welcome menus in our canteen Free parking on the premises Regular corporate events Ideas management with attractive cash and material premiums Open duz culture for a working environment at eye level